Global Import Regulations for

Paraguay

General Market Condition: No Restrictions, but Public Institutions Cannot Buy

Source: Report from CS Post (via E-Mail), 25 April 2003

Are there special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment?

Paraguay has no special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment.

If a manufacturer or its agent has registered a medical device in the country, can a third party legally import the same device in used /refurbished condition without the used device being subjected to new safety inspections, etc.?

Yes. Paraguay has no safety inspection requirements.

Can public health institutions buy used or refurbished medical devices?

Public health government institutions cannot buy used or refurbished medical devices.

Is there a market for used or refurbished medical devices?

There is a market for used and refurbished medical devices.

What types of used or refurbished medical equipment are in the greatest demand?

Diagnostic imaging equipment is in the greatest demand.

Peru

General Market Condition: Restricted in Practice not Law

Source: Report from CS Post (via Cable), 5 April 2002

Summary

There is no explicit restriction on the importation of used/refurbished medical equipment into Peru. However, as a matter of practice over recent years, the Directorate General of Pharmaceuticals, Inputs and Drugs (Dirección General de Medicamentos, Insumos y Drogas—DIGEMID) of the Ministry of Health is not authorizing the import of used medical equipment and devices.

By law, public health hospitals, social security hospitals and armed forces hospitals can buy only new medical equipment and devices. Private sector clinics and hospitals can purchase used medical equipment.

Imports of general used equipment are treated the same as imports of new equipment. Under General Health Law No. 26842, imports of medical equipment and devices require a ‘Sanitary Registration’ issued by DIGEMID of the Ministry of Health. It is necessary to obtain the Certificate to Foreign Governmen’ from the U.S. Food and Drug Administration (FDA) to be able to get the Sanitary Registration. The inspection certificate issued by one of the three authorized companies, i.e., SGS, COTECNA, and Bureau Veritas, is also required. These companies charge US $250 for imports valued from $2,000 to $25,000 and 1 percent for imports valued overr US $25,000.

Both new and used products pay 7-percent or 12-percent custom duties applicable on the CIF value, in addition to the 18-percent sales tax.

In addition, the Customs Circular 1071 dated September 16, 1999, states that the Sanitary Registration is mandatory to release the products from customs. However, as a matter of practice DIGEMID only issues the Sanitary Registration for new medical equipment. The latter circular only authorizes the import of used medical equipment when it is for the immediate use by a professional returning to Peru.

Philippines

General Market Condition: No Restrictions, but Public Institutions Cannot Buy

Source: ISA Radiological Equipment, 21 August 2002 [Extracts]

Market Highlights and Best Prospects:

The average total market size of the radiology equipment market from 1999 to 2001 is approximately US$13 million. Industry players project that market demand will grow by fifteen percent in the next three years due to hospital expansion, development of Department of Health projects and population growth. Private hospitals in Metro Manila and its suburbs, which have the financial resources for upgrading will drive demand in this sector. Imports account for 98% of total radiology equipment; prototypes and locally assembled equipment from surplus materials account for the remaining 2%. Prototypes, however, are not sold commercially and are used only in Department of Health equipment laboratory tests and training centers.

There are locally produced equipment parts but their value is insignificant. More often, it is cheaper to import parts from China than to manufacture locally. France, Germany, the Netherlands and Hong Kong also supply radiology equipment parts and accessories (high-tension generators, control panels and desks, screens and examination tables).

The period of 1999 to 2001 also saw the completion of the much-touted Asian Hospital in Alabang, Muntinlupa. The hospital is managed by the Singapore-based Vista Healthcare Asia Pte. Ltd. GE Medical Systems, the largest U.S. company in the medical business in the Philippines, outfitted the Asian Hospital's various specialty departments. This 250-bed hospital showcases the best technology that U.S. companies can offer – from hospital design and administration, to healthcare service delivery and medical/laboratory equipment. GE dealers also report that they installed 12 out of the 17 X-ray machines in 2001—7 new equipment and 5 refurbished—an accomplishment despite what many businessmen considered "hard times." There is a growing market for refurbished medical equipment. Private hospitals and clinics outside metropolitan Manila tend to purchase used/refurbished equipment, whether x-ray, cardiology or surgery. To date, about 55% of all medical equipment supplied to hospitals and clinics are refurbished, according to equipment dealers.

D. Market Access:

The Philippines imposes a 3% tariff duty and a 10% value-added tax (VAT) on imported medical equipment. The Bureau of Radiation Health Services, Department of Health, requires that radiation emitting devices be registered before introduction to the local market. Local testing is required only for certain radiation equipment. There are no import quotas for products in this sector, including used and refurbished medical equipment.

Source: Report from CS Post (via E-Mail), 1 July 2002

Medical Device Regulatory Requirements for the Philippines, July 1, 2002

There are no special restrictions on the importation of medical equipment provided these are imported by duly authorized and licensed medical equipment importers and distributors. Importers/Distributors must secure this License to Operate (LTO) from the Department of Health.

The Bureau of Health Devices does not impose any restriction on used medical equipment except that these should be comparable in safety with new equipment. Refurbishers of used equipment must obtain a clearance from the original equipment manufacturer and must conform to good manufacturing practices. Refurbishers are also not allowed to distribute commercially, any device that has not been produced in conformity with such requirement.

Only X-ray machines and other radiation-emitting devices require registration before introduction to the local market. Local testing is required only for certain radiation equipment like the Linear Accelerator.

The validity period for initial registration of a medical device is one year. Under Bureau of Food & Drug Administration (BFAD) Circular #05, series of 1998, length of renewal registrations has been extended to five years.

The Bureau of Health Devices and Technology under the Department of Health is the primary agency that monitors medical equipment (ionizing and non-ionizing, radiation dosimetry, radiation, non-radiation, laboratory, medical physics, etc.)

The Philippines imposes a 3-percent tariff duty and a 10-percent value-added tax (VAT) on imported medical equipment, including used and refurbished. As a policy, however, the government can only procure new equipment.

The Department of Health or the health units under the local government supervision may, however, accept used equipment if these are donated, provided the equipment includes an operation manual to ensure its safe operation. The government discourages Philippine importers from buying used equipment without proper documentation and operation handbook.

There are good opportunities for used/refurbished medical equipment: it accounts for 40 percent of the Philippine market. Like new equipment, the most promising sub-sectors are X-ray equipment and medical/surgical instruments. Major end-users are the primary and secondary hospitals in Metro Manila and the provinces.

There are 3 classifications of Philippine hospitals:

• 
  Primary Hospitals—capable of handling general medicine, pediatrics, obstetrics and minor surgeries;
  
• 
  Secondary Hospitals—can handle all services available in a primary hospital including gynecology, general surgery, and other ancillary services;
  
• 
  Tertiary Hospitals—fully departmentalized hospitals that can handle more specialized services than secondary hospitals.
  

Contact Information

Department of Health of the Philippines:
San Lazaro Compound, Tayuman, Sta. Cruz
Manila, Philippines 1003

Website: www.doh.gov.ph/bfad

Organization E-mail: [e-mail]

Telephone: [phone]

Fax: [phone]

Contacts

Dr. Manuel Dayrit
Secretary, Department of Health

Ms. Agnette P. Peralta

Director, Bureau of Health Devices and Technology

Engineer Cecilia Matienzo

Engineer V, Bureau of Health Devices and Technology